Comparing two medicines for relieving pain due to needle prick for glucose drip

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/10/058562
• Lead Sponsor: Dr Shagun Bhatia Shah

Brief Summary

This prospective interventional, two-arm, single-centric randomised controlled study aims to compare a vapocoolant based no-prick technique of preventing pain due to intravenous cannulation with the local anaesthetic injection technique and shall include 80 adult ASA I-II patients of either sex, aged 18-60 years, weighing 45-80kg, undergoing IV cannulation with 20G or 18G cannula. Exclusion criteria comprise patient refusal to give consent, local anaesthetic allergy and patients requiring more than one attempt for intravenous cannulation. The study will be conducted at Rajiv Gandhi Cancer Institute and Research Centre. The patients shall be randomly allocated into two groups: local anaesthetic injection group (Group-LA; n=40), and vapocoolant spray group (Group-VS; n=40). Our primary outcome measures would be pain score measured on a linear 100mm Visual analog scale (VAS) at the time of local anaesthetic prick/vapocoolant spray, intravenous cannula introduction, and 1min post intravenous cannulation. Our secondary outcome measures would be VAS for anxiety score, heart rate (HR), mean arterial pressure (MAP) and perfusion index (PI) measured at specific time points (baseline, intravenous cannula introduction, and 1min post intravenous cannulation).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-10
• Study Start: 2023-10-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Weighing 40-80kg, undergoing intravenous cannulation with 20G or 18G cannula.

Exclusion Criteria

Refusal to give consent, Local Anaesthetic allergy, Patients requiring more than one attempt for intravenous cannulation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain visual analog scale (VAS)score	0 minute: At the time of local anaesthetic prick/vapocoolant spray | 1 minute : After local anaesthetic prick/vapocoolant spray at the time of IV cannulation | 2 minutes : After local anaesthetic prick/vapocoolant spray

Secondary Outcome Measures

Name	Time	Method
Anxiety visual analog scale (VAS) score	Heart rate (HR)

Trial Locations

Locations (1)

Rajiv Gandhi Cancer Institute and Research Centre; 🇮🇳 West, DELHI, India

Rajiv Gandhi Cancer Institute and Research Centre

🇮🇳West, DELHI, India

Dr Shagun Bhatia Shah

Principal investigator

9891769779

drshagun_2010@rediffmail.com